MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number PVS25

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

The manufacturer was informed of a collapsing difficulty event.Based on the information provided, the perceval s valve size l was attempted to be implanted on (b)(6) 2021.This did not happen due to the collapsing difficulty.Surgeon mentioned that in the last step of preparing the valve, the proximal part of the holder could not ''grab'' the inflow part of the valve.The surgeon tried to repeat all the steps again but could not collapse the valve in the second attempt as well.Then decided not to implant this valve.Therefore, the valve was not implanted.According to the additional information received, this issue did not cause a delay to the surgery and bypass time and the patient was stable during the operation.

Manufacturer Narrative

The pvs 25/l was returned to manufacturer for investigation.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The replication of collapsing phases was performed using the returned pvs 25/l and a demo accessory kit, in order to reproduce the reported event.No problems were encountered positioning the returned valve.At a first attempt of collapsing replication the valve was reduced and captured buy the dual holder, but some portion of nitinol structures were found overlapped.The replication was then repeated and, during the second attempt the outflow crown showed the tendency to escape inside the dual collapsar, making it impossible to complete the procedure.The manufacturing and material records for the valve were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.Based on the investigation and analysis performed on the device, it was possible to reproduce the collapsing difficulty reported from the field.Based on the manufacturer's experience this kind of issue can happen due to different reasons that include: deformation or local overload that can induce the effect to be able to collapse (even in not perfect way) at a first procedure but followed to serious difficulty.The occurrence of unfavorable concomitance of tolerances between the valve and the accessories that are no size dedicated (s/m and l/xl).For this second aspect, a corrective and preventive action was opened and it is currently ongoing in order to avoid the occurrence of this type of problem.However, since the accessories involved in the reported event were not returned to the manufacturer for investigation, a definitive root cause of this event can not be established.As no further investigation is possible, the case is considered closed at this time.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 13510116
• MDR Text Key: 285669227
• Report Number: 3004478276-2022-00121
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)200719
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other